Graviola Group – FDA Warning Letter

The FDA issued a Warning Letter to Graviola Group on April 2, 2014, following a February 2014 review of their website, www.graviolagroup.com. The FDA determined that the product "Graviola Extract" is promoted for conditions that cause it to be an unapproved and misbranded drug under the Federal Food, Drug, and Cosmetic Act.

The website made numerous therapeutic claims, including that Graviola Extract supports cancer treatments and helps cure various cancers (prostate, breast, lung, colon, uterus, non-Hodgkin, melanoma, skin, kidney, ovary), acts as a "natural Chemotherapy," "kills cancer cells without harming healthy cells," and "prevents the growth of malignant tumors." It also cited scientific studies and claimed the product is "10,000 times more powerful" than adriamycin (chemotherapy) in killing cancer cells. Additional claims included benefits for asthma, hypertension, diabetes, liver disorders, and properties such as antibacterial, antiparasitic, and antitumor. Testimonials on the website's videos further supported these claims for conditions like endometrial cancer, breast cancer, and irritable colon syndrome.

These claims establish Graviola Extract as a drug intended for the cure, mitigation, treatment, or prevention of disease. Since it is not generally recognized as safe and effective for these uses, it is considered a "new drug" requiring prior FDA approval, which it lacks. Furthermore, the